Cleared Traditional

K053657 - POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE

K053657 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVES, manufactured by Pt Mahakarya Inti Buana. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K053657 · Pt Mahakarya Inti Buana · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
70d
Days
Class 1
Risk

K053657 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Pt Mahakarya Inti Buana (Morawa, Sumut, ID). The FDA issued a Cleared decision on February 13, 2006 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pt Mahakarya Inti Buana devices

FDA 510(k) Submission Details - K053657

510(k) Number K053657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date February 13, 2006
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 765
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K053657.
TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING
K060073 · Shen Wei (Usa), Inc. · May 2006
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
K060771 · Kossan Latex Industries(M)Sdn Bhd · May 2006
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)
K060753 · Siam Sempermed Corp., Ltd. · Apr 2006
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
K052502 · Yty Industry (Manjung) Sdn Bhd · Nov 2005
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
K052877 · Syntex Healthcare Products Co., Ltd. · Nov 2005
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
K052890 · Siam Sempermed Corp., Ltd. · Oct 2005